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Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI

NCT02793661 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-09-05

No results posted yet for this study

Summary

The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.

Conditions

Interventions

DEVICE

RenalGuard

Replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient's intravascular fluid volume. Diuretic is administered to reach an optimum urine flow and protect efficiently the patients' kidneys.

OTHER

Control

Hydration protocol following ESC Guidelines 2014

Sponsors & Collaborators

  • RenalGuard Solutions, Inc.

    collaborator INDUSTRY

  • European Cardiovascular Research Center

    lead NETWORK

Principal Investigators

  • Andrew Halpert · RenalGuard Solutions, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-31
Completion
2018-05-31

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793661 on ClinicalTrials.gov